Medical Device Manufacturer · US , Newark , DE

Siemens Healthcare Diagnostics - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 2008
92
Total
92
Cleared
0
Denied
92 devices
51-75 of 92
Cleared Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631 · CDD
Chemistry · 80d
Cleared Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · LTT
Microbiology · 209d
Cleared Jan 14, 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE...
K091867 · CDZ
Chemistry · 205d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · LIP
Microbiology · 222d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993 · JJX
Chemistry · 53d
Cleared Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
K091916 · DAP
Hematology · 121d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · LON
Microbiology · 30d
Cleared Oct 21, 2009
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE,...
K092283 · DFZ
Immunology · 84d
Cleared Oct 09, 2009
CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
K091216 · JIL
Chemistry · 165d
Cleared Aug 14, 2009
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS
K091123 · JJX
Chemistry · 119d
Cleared Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K091289 · DHB
Immunology · 97d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · LTT
Microbiology · 83d
Cleared Jun 01, 2009
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
K090900 · DKB
Toxicology · 61d
Cleared May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · JBQ
Hematology · 339d
Cleared May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K090257 · DHB
Immunology · 113d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · JLW
Chemistry · 135d
Cleared Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION...
K090594 · CFN
Immunology · 55d
Cleared Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · LOJ
Immunology · 84d
Cleared Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL),...
K083386 · CJY
Chemistry · 136d
Cleared Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT,...
K083487 · NRP
Toxicology · 125d
Cleared Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN...
K083445 · CFN
Immunology · 123d
Cleared Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083853 · DHB
Immunology · 90d
Cleared Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR,...
K083463 · JZG
Immunology · 109d
Cleared Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083314 · DHB
Immunology · 121d
Cleared Mar 11, 2009
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR,...
K083906 · NDY
Chemistry · 71d

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